36248 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

(NVCASE) administered by the National

Institute of Standards and Technology

(NIST) of the U.S. Department of

Commerce to recognize one or more

accreditation bodies that, in turn, will

assess potential U.S. CAB’s seeking to

be designated under the MRA to assess

medical devices produced for the EC

market. FDA will consider the

recommendations made by the

recognized accreditation bodies from

June 1, 1998, until October 1, 1998,

review the list of recommended CAB’s,

and then designate U.S. CAB’s that meet

criteria for technical competence set

forth in the Medical Devices Annex,

assuming the MRA enters into force and

a final rule on the MRA becomes

effective. FDA intends to conduct

training for EC CAB’s from October 14

to 23, 1998.

Assessment of prospective U.S. CAB’s

for purposes of conducting quality

system evaluations and product typeexamination and verifications will be

conducted under the NVCASE program

under the procedures set forth in 15

CFR part 286. Prospective U.S. CAB’s

and accreditation bodies should contact

NIST for additional information.

Applications for designation should

include sufficient information to

address the qualifications for CAB’s set

forth in Article 1, Paragraph 1 of the

Medical Devices Annex of the MRA. At

a minimum, qualified U.S. CAB’s

should have knowledge of:

(1) Council Directive 90/385/EEC of

June 20, 1990, on active implantable

medical devices OJ No. L 189, 20.7.1990

(p. 17). Conformity assessment

procedures: Annex 2 (with the

exception of section 4), Annex 4, and

Annex 5.

(2) Council Directive 93/42/EEC of

June 14, 1993, on medical devices OJ

No. L 169, 12.7.1993 (p. 1). Conformity

assessment procedures: Annex 2 (with

the exception of section 4), Annex 3,

Annex 4, Annex 5, and Annex 6.

Assuming the MRA enters into force

and a final rule becomes effective,

designation of EC CAB’s for the purpose

of conducting quality system

evaluations and premarket 510(k)

evaluations will be conducted in accord

with the Medical Devices Annex. At a

minimum, qualified EC CAB’s should

have knowledge of:

(1) The Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321 et seq.),

(2) The Public Health Service Act (42

U.S.C. 201 et seq.),

(3) Regulations of the United States

Food and Drug Administration (21 CFR

parts 800 to 1299); and

(4) The Federal Register document on

the pilot program for third-party review

of selected premarket notifications for

medical devices that was published on

April 3, 1996 (61 FR 14789 at 14796).

Prospective EC CAB’s should contact

their European Regulatory Authority,

not FDA, for further information.

Following designation, the EC CAB’s

can expect to be monitored through

FDA surveillance audits at intervals

determined by the agency.

III. Environmental Impact

The agency has determined under 21

CFR 25.34(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

IV. Analysis of Impacts

FDA has examined the impacts of the

U.S./EC MRA third party review

program under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354), as amended by subtitle D of

the Small Business Regulatory Fairness

Act of 1996 (Pub. L. 104–121), and the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this voluntary program is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

program is not a significant regulatory

action as defined by the Executive Order

and so is not subject to review under the

Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. This regulation provides

alternative review options for certain

types of submissions. This is a

voluntary program which imposes no

additional requirements on regulated

industry. Accordingly, the agency

certifies that the program, if

implemented, would not have a

significant economic impact on small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

Dated: June 24, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17597 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Circulatory System Devices Panel of

the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Circulatory

System Devices Panel of the Medical

Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on July 21 and 22, 1998, 8 a.m. to

5 p.m.

Location: Holiday Inn, Ballroom, Two

Montgomery Village Ave., Gaithersburg,

MD.

Contact Person: John E. Stuhlmuller,

Center for Devices and Radiological

Health (HFZ–450), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–443–8243,

ext. 157, or FDA Advisory Committee

Information Line, 1–800–741–8138

(301–443–0572 in the Washington, DC

area), code 12625. Please call the

Information Line for up-to-date

information on this meeting.

Agenda: On July 21, 1998, the

committee will discuss, make

recommendations, and vote on a

premarket approval application (PMA)

for a cardiac ablation device for

ventricular tachycardia. On July 22,

1998, the committee is being asked to

provide input to the agency regarding

the design of clinical trials to support

PMA’s for cardiac ablation devices

intended to treat atrial fibrillation and

atrial flutter. Of particular concern are

the following issues: (1) What are the

appropriate controls to be used in such

trials? (2) What are the appropriate

safety and efficacy measures? and (3)

When should assessments of these

measures be made?

Procedure: Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by July 10, 1998. Oral

presentations from the public will be

scheduled between approximately 8

a.m. and 8:30 a.m. Near the end of
Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36249

committee deliberations on both days, a

30-minute open public hearing will be

conducted for interested persons to

address issues specific to the

submission before the committee. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before July 10, 1998, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: June 26, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17596 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–379]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) the necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Extension of a currently

approved collection; Title of

Information Collection: The Financial

Statement of Debtor and Supporting

Regulation 42 CFR 405.376; Form No.:

HCFA–379, OMB #0938–0270; Use: This

form is used to collect financial

information which is needed to evaluate

requests from physician/suppliers to

pay indebtness under extended

repayment schedule, or to compromise

a debt for less than the full amount.

Frequency: As needed; Affected Public:

Business or other for-profit, Not-forprofit institutions; Number of

Respondents: 500; Total Annual

Responses: 500; Total Annual Hours:

1,000.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, E-mail

your request, including your address

and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the OMB Desk Officer designated at the

following address: OMB Human

Resources and Housing Branch,

Attention: Allison Eydt, New Executive

Office Building, Room 10235,

Washington, D.C. 20503.

Dated: June 18, 1998.

John P. Burke III,

HCFA Reports Clearance Officer, HCFA,

Office of Information Services, Information

Technology Investment Management Group,

Division of HCFA Enterprise Standards.

[FR Doc. 98–17557 Filed 7–1–98; 8:45 am]

BILLING CODE 4120–03P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[Document Identifier: HCFA–R–246]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

AGENCY: Health Care Financing

Administration, HHS.

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services, is publishing the

following summary of proposed

collections for public comment.

Interested persons are invited to send

comments regarding this burden

estimate or any other aspect of this

collection of information, including any

of the following subjects: (1) The

necessity and utility of the proposed

information collection for the proper

performance of the agency’s functions;

(2) the accuracy of the estimated

burden; (3) ways to enhance the quality,

utility, and clarity of the information to

be collected; and (4) the use of

automated collection techniques or

other forms of information technology to

minimize the information collection

burden.

We are, however, requesting an

emergency review of the information

collection referenced below. In

compliance with the requirement of

section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, we have

submitted to the Office of Management

and Budget (OMB) the following

requirements for emergency review. We

are requesting an emergency review

because the collection of this

information is needed before the

expiration of the normal time limits

under OMB’s regulations at 5 CFR, Part

1320. This collection is necessary to

ensure compliance with section 1876 of

the Social Security Act. Section 1876(I)

of the Social Security Act (the Act) sets

forth several criteria for HMO contracts.

As relevant here, section 1876(I)(3) of

the Act gives the Secretary, or her

designee the authority to incorporate

additional contractual terms and

conditions that are consistent with

section 1876. These statutorily

mandated contract provisions have been

implemented in the regulations at 42

CFR 417.470, et seq which reference 42

CFR 417.126(a) which states that each

HMO must have an effective procedure

to develop, compile, evaluate, and

report to HCFA, to its enrollees, and to

the general public, at the times and in

the manner that HCFA requires, the

following: the cost of its operations; the

patterns of utilization of its services; the

availability, accessibility and

acceptability of its services; to the extent

practical, developments in the health

status of its enrollees; information

demonstrating that the HMO has a

fiscally sound operation and other

matters that HCFA may require. Without

emergency approval HCFA will be

unable to monitor the quality of care

received by beneficiaries in managed

care measured through the Consumer

Assessment of Health Plans Study

(CAHPS) survey asking beneficiaries

about their experiences with their plan.

As a result, public harm is likely to

result because HCFA will be unable to

monitor the quality of care received by

beneficiaries.

HCFA is requesting OMB review and

approval of this collection within 6

working days of publication of this

notice in the Federal Register, with a

180-day approval period. Written

comments and recommendations will be

accepted from the public if received by

the individuals designated below by 5

working days of the publication of this

notice. During this 180-day period, we